The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

18926–18950 of 32108

  • SevereFDA (Food)·F-0068-2017·2016-10-19

    Publix Guava Strip Danish Recalled for Metal Shavings

    Gold Standard Baking is recalling Publix Guava Strip Danishes due to the presence of small metal shavings.

    Product
    Publix Guava Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802. UPC: 002-19562-00000
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0064-2017·2016-10-19

    Gold Standard Baking Recalls Strawberry Cheese Danish Due to Metal Shavings

    Gold Standard Baking is recalling The Bakery Strawberry Cheese Danish because of the presence of small metal shavings. The product was distributed nationwide by Walmart.

    Product
    The Bakery Strawberry Cheese Danish | Net Wt 14 OZ (397g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 078742100401
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0052-2017·2016-10-19

    Pharmedium Recalls Hydromorphone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 450 syringes of Hydromorphone HCl because stability data does not support the expiry dates, posing a risk of loss of potency.

    Product
    HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0018-2017·2016-10-19

    Leiter's Compounding Recalls Vancomycin Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Vancomycin 10 mg/mL injection vials because they were produced using recalled filters, raising concerns about sterility.

    Product
    Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0077-2017·2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 935 syringes of morphine sulfate because stability data does not support the expiry dates, posing a risk of reduced potency.

    Product
    morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0087-2017·2016-10-19

    Pharmedium Recalls Phenylephrine Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling specific lots of Phenylephrine HCl syringes because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0009-2017·2016-10-19

    Weis Markets Recalls Bakery Products Due to Potential Metal Fragments

    Weis Markets is voluntarily recalling 30 bakery products, including muffins and cookies, due to the potential presence of small metal fragments in the sugar topping.

    Product
    Gourmet Blueberry Monster Muffins (4 count)
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0013-2017·2016-10-19

    Leiter's Compounding Recalls Ophthalmic Solution Due to Sterility Concerns

    Leiter's Compounding is recalling Cyclopentolate HCl, Tropicamide, and Phenylephrine HCl ophthalmic solution because the filters used to produce the products were recalled, creating a lack of assurance of sterility.

    Product
    Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0040-2017·2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Stability Data Concerns

    Pharmedium Services is recalling 1,561 syringes of fentanyl citrate because stability data does not support the expiry dates, posing a risk of potency loss.

    Product
    fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0075-2017·2016-10-19

    Pharmedium Recalls Midazolam Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 26,079 syringes of midazolam HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0042-2017·2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 1,735 syringes of fentanyl citrate because stability data does not support the expiration dates, posing a risk of reduced drug potency.

    Product
    fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0090-2017·2016-10-19

    Pharmedium Recalls Succinylcholine Chloride Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 2,495 syringes of succinylcholine chloride injection because stability data does not support the expiration dates, posing a risk of loss of potency.

    Product
    succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0024-2017·2016-10-19

    Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is voluntarily recalling 11,844 vials of Amikacin Sulfate Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0070-2017·2016-10-19

    Pharmedium Recalls Methadone Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 7,006 syringes of methadone HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0036-2017·2016-10-19

    Pharmedium Recalls Fentanyl Syringes Due to Potential Loss of Potency

    Pharmedium Services, LLC is recalling 110 syringes of fentanyl citrate because stability data does not support the expiry date, posing a risk of reduced drug potency.

    Product
    fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0056-2017·2016-10-19

    Pharmedium Recalls Ketamine HCl Injection Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 12,173 syringes of ketamine HCl Injection because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0100-2017·2016-10-19

    Allergan Recalls Tazorac Gel 0.05% Due to Content Uniformity Failures

    Allergan Sales, LLC is recalling 17,112 tubes of Tazorac (tazarotene) Gel 0.05% because the product failed content uniformity specifications.

    Product
    TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0010-2017·2016-10-19

    Leiter's Compounding Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns

    Leiter's Compounding is recalling Atropine Sulfate 0.01% ophthalmic solution because the filters used to produce the products were recalled, raising concerns about sterility.

    Product
    Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2017·2016-10-19

    Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is voluntarily recalling 27,547 vials of Amikacin Sulfate Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V758000·2016-10-19

    Mercedes-Benz Recalls 2017 E300 Sedans for Fuel Pump Wiring Defect

    Mercedes-Benz is recalling 2017 E300 Sedans because the rear seat frame may damage fuel pump wiring, potentially causing an engine stall and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0091-2017·2016-10-19

    Pharmedium Recalls Lidocaine Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 4,400 syringes of lidocaine HCl 1% because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0073-2017·2016-10-19

    Pharmedium Recalls Midazolam Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 1,700 syringes of midazolam HCl because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0080-2017·2016-10-19

    Pharmedium Recalls Morphine Sulfate Syringes Due to Stability Data Concerns

    Pharmedium Services, LLC is recalling 545 syringes of morphine sulfate because stability data does not support the expiration dates, posing a risk of reduced potency.

    Product
    morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0093-2017·2016-10-19

    Pharmedium Recalls Subpotent Fentanyl Citrate Syringes Nationwide

    Pharmedium Services, LLC is recalling 500 syringes of fentanyl citrate due to confirmed subpotency. The product was distributed nationwide.

    Product
    fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
    Category
    Drug
    Distribution
    Distributed nationwide